Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
240 participants
INTERVENTIONAL
2023-01-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group
Gandouling
Gandouling
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Control group
Zinc gluconate
Gandouling
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Interventions
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Gandouling
The experimental group was given gandouling tablet + zinc gluconate simulant; The course of treatment was 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The diagnosis of TCM syndromes complies with the syndrome of phlegm and blood stasis; Other copper-removing drugs
* Patients who have been treated with complexing agents for copper-removing treatment can enter the study after a 2-week washout period
* Age ≥15 years
* Informed consent of patients or legal representatives, And sign the informed consent form.
Exclusion Criteria
* Severe liver Type WD patients: Decompensated liver cirrhosis or liver cancer, manifested as portal hypertension, ascites, splenomegaly (WBC\<3.0\*109/L, PLT\<50\*1012/L), esophageal varices, gastrointestinal bleeding, Moderate to severe anemia or hepatic encephalopathy; severe liver fibrosis shown by imaging or any laboratory abnormality (UWDRS liver function score ≥ 17 points)
* Moderate to severe depression, recent suicidal thoughts or behavior, Severe psychiatric symptoms (UWDRS Part III Psychiatric Symptom Score ≥ 54 points)
* History of epileptic seizures within 6 months
* Complicated with serious diseases such as brain tumors, brain trauma, blood diseases, Cardiogenic diseases, HIV, etc.
* Nephritis, nephrotic syndrome, or kidney disease stage 3 or more
* Pregnant, planned pregnancy or breastfeeding women
* Cognitive dysfunction MMSE≤26 points
* Those who are currently participating in other clinical trials
* Cannot comply with the follow-up plan
15 Years
65 Years
ALL
No
Sponsors
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Jun Li
OTHER
Responsible Party
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Jun Li
associate chief physician
Locations
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Jun Li
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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References
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Ding Y, Cao K, Yang W, Hu S, Zhang J, Yang Y, Zhang X. Mapping neurological symptoms and muscle tension representations in impaired gray matter volume of Wilson disease. Front Neurol. 2025 Jun 5;16:1560848. doi: 10.3389/fneur.2025.1560848. eCollection 2025.
Other Identifiers
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GWPS
Identifier Type: -
Identifier Source: org_study_id
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